Kornimate/medical-research-clean huggingface dataset:
application of 3d printing technology in subtalar arthrodesis

Conditions: Ankle Injuries

Summary: this study aims to use 3d printing personalized plate to locate the position in which the k-wires would be drilled to save operation time and decrease the number of times that the k-wires are drilled.

subtalar arthrodesis is a standard procedure for treating joint injuries in terminal stage. in this study, in order to improve efficacy and shorten the operation time, personalized plate is prepared before surgery. during the surgery, the articular cartilage is scraped, then the fusion joint is reset to the functional position; the 2-2mm kirschner wires are drilled with the assistance of the personalized plate,then the position of the fusion joint as well as the kirschner wires are confirmed under the c-arm; lastly, cannulated screws are screwed in along the kirschner wires for effective fixation. in the past surgeries without personalized plate, surgeons could only rely on their experience to locate the position for drilling and then confirm under the c-arm. this would prolong the operation time and be more traumatic to the patients. using 3d printing personalized plate can solve this problem. the preparation procedure for the personalized plate: firstly, ankle model are established according to the patient's ct scan data, then select modular pieces to prepare the personalized plate, sterilize it for future use. apply conventional surgical treatment to the subtalar surface, reset the fusion joint to the functional position, and drill 2-2mm kirschner wires with the guidance of the plate. if the locations of the fusion joint and the kirschner wires are satisfying under the c-arm inspection, drill the hollow screw for final fixation.

Eligibility criteria:
inclusion criteria: * patients who receive subtalar arthrodesis and consider internal fixation with screws exclusion criteria: * patients who receive subtalar arthrodesis but do not consider internal fixation with screws

Keywords: subtalar joint arthrodesis 3d printing
p2x7 receptor, inflammation and neurodegenerative diseases

Conditions: Neuro-Degenerative Disease

Summary: parkinson disease (pd) is a chronic degenerative disease characterized by a progressive loss of dopaminergic neurons in the substantia nigra. its pathophysiological mechanisms are still partially unknown; a main role seems to be played by chronic neuroinflammation. a few reports have addressed the possible involvement of the inflammasome in pd, just describing the protective effect of p2x7 purinergic receptor (p2x7r) blockers in murine models of the disease and in microglial cells, where nlrp3 is activated by α-synuclein, triggering a neuroinflammation that contributes to degeneration of dopaminergic neurons. it is still unclear whether, in addition to the increased brain expression and function of the nucleotide-binding domain, leucine-rich repeat, pyrin domain containing type 3 (nlrp3) inflammasome platform, a systemic activation of such complex might participate in the pathogenesis of pd, which could be the role of the p2x7r in this scenario, and whether such patterns undergo any specific epigenetic regulation. the present study has been designed to address these issues.

the day of the study patientes underwent a complete clinical evaluation and assessment of psycho-physical abilities using specific test such as mini-mental state examination (mmse), cognitive alzheimer's disease assessment scale (adas-cog), clinical dementia rating scale, unified parkinson's disease rating scale (updrs). blood samples were collected from an antecubital vein to assess serum and plasma aliquots for blood routine analysis and rna and protein extraction from circulating lymphomonocytes. to explore a putative epigenetic regulation of such complex scenario some circulating mirnas likely involved in the pathogenesis of neurological diseases and neuro-inflammation will be measured. expression and functional activity of p2x7r-inflammasome complex will be measured by pcr and wb. acute phase cytokines inflammasome-related levels will be determined by elisa. biochemical parameters (fasting glucose, lipid profile, serum creatinine, uric acid) will be measured by standard methods in the biochemistry laboratory of the university hospital in pisa. the same determinations will be repeated after one year from the first visit.

Eligibility criteria:
inclusion criteria: * newly-diagnosed pd or ad; * no previous specific treatment; * no systemic inflammatory or immunological disease and/or cancer; * no anti-inflammatory drugs assumed in the three months preceding the enrolment; * patients able to consent. exclusion criteria: * history of strokes or any neurological disease; * patients assuming neuroleptic drugs; * atypical symptoms at onset.

Keywords: alzheimer disease parkinson disease p2x7 receptor
to evaluate the effects of sb-649868 (10, 30 mg and 60 mg) on subjects with primary insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: this study to evaluate the effects of sb-649868 (10, 30 mg and 60 mg) on sleep continuity, psg sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia


Eligibility criteria:
inclusion criteria: * male * 18-64 years of age (inclusive), * diagnosis of primary insomnia who have had symptoms for at least three months. exclusion criteria: * any clinically significant unstable medical or surgical condition (treated or untreated). * any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).

Keywords: primary insomnia psg sleep recordings daytime cognitive function insomnia sb-649868
mpa auc monitoring in patients receiving mmf for diffuse cutaneous or pulmonary involvement in systemic sclerosis

Conditions: Systemic Sclerosis

Summary: to define a target value of auc mpa to improve the modified rodnan score and / or respiratory impairment (dlco or fvc) at one year in patients receiving mmf for the treatment of diffuse cutaneous or interstitial lung damage of systemic sclerosis.

in the treatment of autoimmune diseases, mmf is almost always prescribed at a fixed dose, regardless of auc, or based on the target of auc determined for organ transplantation. one study looked at determining an "effective" auc threshold in systemic lupus erythematosus, which appears to be 35mg / h / l. this was also done for anca vasculitis. we therefore conducted this study to determine a correlation between auc mpa and the effectiveness of mmf in systemic sclerosis. prospective, observational, open study. main objective: define a target value of auc mpa to improve the modified rodnan score and / or respiratory impairment (dlco or fvc) at one year in patients receiving mmf for the treatment of diffuse skin involvement or pulmonary function in systemic sclerosis. the main endpoint will be evaluated on the evolution of the modified rodnan score at 1 year after the initiation of mmf and / or the evolution of fvc and dlco at 1 year after the initiation of mmf.

Eligibility criteria:
inclusion criteria: * systemic sclerosis meeting the acr / eular criteria of 2013 * equal or more than 18 years old, able to freely consent to study * in patients treated for skin damage: * diffuse skin sclerosis (rising above the elbows and / or knees) * first clinical sign of systemic sclerosis outside of raynaud's phenomenon going back less than three years * failure to take other concomitant immunosuppressive treatments or in the last 3 months except corticosteroids. * in patients treated for lung damage: * interstitial lung damage identified on chest ct, chest x-ray * any duration of progression of systemic scleroderma * prescription of mmf in first line or in relay of a treatment with cyclophosphamide. * absence of biotherapy in the last 6 months. exclusion criteria: -

Keywords: systemic sclerosis diffuse interstitial lung disease therapeutic drug monitoring (tdm) mycophenolate mofetil
the efficacy of rhinophototherapy compared to intranasal corticosteroids on the nasal mucosa

Conditions: Allergic Rhinitis

Summary: the aim of this study to compare the efficacy of rhinophototherapy to intranasal corticosteroids on the the nasal mucosa of allergic rhinitis patients. the main question to answer is: does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids? the hypothesis for this study is intranasal phototherapy will reduce mucosal inflammation without mucosal damage and is comparable to intranasal steroids in allergic rhinitis patients

there are several specific objectives for this study: 1. to subjectively and objectively compare the efficacy of intranasal phototherapy and intranasal corticosteroids in treating allergic rhinitis via assessment of rhinomanometry, peak nasal inspiratory flow (pnif) and visual analogue scale(vas) score. 2. to determine mucosal inflammatory cells changes (eosinophils, neutrophils, mast cells) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids. 3. to determine mucosal damage (fibrosis, mucosal ulceration , squamous metaplasia) between patients treated with intranasal rhinophototherapy and intranasal corticosteroids. patients who meet the criteria to join the study will be randomized in a single-blinded manner(investigator). patients will be given information about the study and consent form, patients will be randomized to 2 treatment group (rhinophototherapy and nasonex nasal spray). patients will be evaluated before and after treatment in two weeks time.

Eligibility criteria:
inclusion criteria: * adult patients 18 years and above * newly diagnosed allergic rhinitis * allergic rhinitis is confirmed via positive skin prick test or serum immunoglobulin e exclusion criteria: * anaphylaxis /poorly controlled bronchial asthma * refused nasal biopsy * usage of intranasal corticosteroids and/or antihistamine sprays for the past 1 month * consumption of oral leukotriene receptor antagonist or oral steroids for the past 1 month * concomitant nasal pathology (malignancy, chronic rhinosinusitis with nasal polyposis, severe deviated nasal septum) * bleeding disorder or on anticoagulant/antiplatelet therapy * recent urti/covid-19 within past 14 days * pregnancy
screening protocol for preliminary eligibility determination for adoptive cell therapy trials

Conditions: Neoplasms

Summary: this screening study is intended to determine preliminary eligibility of participants who may be potential candidates for glaxosmithkline's adoptive t-cell therapy studies by screening for appropriate biomarkers. no treatment intervention will occur as part of this screening study.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of locally advanced high-risk eligible tumor types . * participant must be greater than or equal to (\>=)18 years of age (or \>=10 years of age with synovial sarcoma or myxoid/round cell liposarcoma \[mrcls\]) * participants with life expectancy of greater than 6 months * performance status: eastern cooperative oncology group 0-1. exclusion criteria: * any prior treatment with oncology cell and/or gene therapy (unless agreed in advance with sponsor) * prior malignancy not in complete remission. * clinically significant systemic illness * serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, * prior or active demyelinating disease * previous new-york esophageal antigen-1 (ny-eso-1)-specific t cells, ny-eso-1 vaccine, or ny-eso-1 targeting antibody. * previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant.

Keywords: adoptive t-cell therapy hematologic malignancy human leukocyte antigen screening study solid tumors t-cell receptors
evaluation of the smartbx system for breast biopsy

Conditions: Breast Cancer

Summary: performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of: 3. biopsy core length obtained (i.e. collecting all tissue fragments) 4. biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

examination procedure: * biopsy cores will be collected from the breast during us guided biopsy procedure. * the number of cores taken will be decided per the physician discretion according to the clinical demand. * additional two biopsy core will be taken the smartbx cassette. since the smartbx cassette holds two biopsies together, two consecutive cores will be collected using the smartbx. * samples will be photographed for measurements in 2 steps during the process: 1. on the needle notch \[a\]. 2. on the glass slide \[b\]. * standard tissue fixation, processing of the samples in paraffin will be performed unchanged per the pathology laboratory protocols. * embedding of the biopsy cores taken with the smartbx will be embedded using the smartbx mold and tamper. * standard staining and histology analysis will be preformed to the sectioned samples, unchanged per the pathology protocols. • analysis will be preformed to the histological results, and a comparison between the standard procedures samples to the smartbx samples will be performed in terms of - * biopsy core length obtained (i.e. collecting all tissue fragments) * biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

Eligibility criteria:
inclusion criteria: * age 18 years or older * planned for breast biopsy procedure. * signed informed consent. exclusion criteria: o patient's unwilling to participate.

Keywords: breast biopsy
safety study of cta018 injection to treat stage 5 chronic kidney disease

Conditions: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Insufficiency; Chronic Renal Failure

Summary: this study will investigate the levels of cta018 in the body over time (pharmacokinetics, pk) in patients with chronic kidney disease (ckd) and secondary hyperparathyroidism (shpt), undergoing regular hemodialysis. this study will also investigate the safety and effects of different strengths of cta018, on parathyroid hormone (pth) levels.


Eligibility criteria:
inclusion criteria: * body mass index between 18 and 35 * on maintenance hemodialysis three times per week * serum ipth value greater than or equal to 300 pg/ml and lower than or equal to 1000 pg/ml * adjusted or total serum calcium value greater than or equal to 8.4 mg/dl and lower than 10.0 mg/dl * serum phosphorus value greater than or equal to 2.5 mg/dl and lower than or equal to 5.5 mg/dl * serum 25-hydroxyvitamin d level greater than or equal to 15 ng/ml * willing and able to discontinue vitamin d and/or bone metabolism therapy for at least 2 weeks prior to administration of study drug, and the length of study exclusion criteria: * on bisphosphonates for at least three months prior to first dose of study drug * currently taking cytochrome p450 3a inhibitors and/or inducers * abnormal liver functions

Keywords: parathyroid diseases renal insufficiency kidney failure, chronic hyperparathyroidism, secondary vitamin d hyperparathyroidism renal insufficiency, chronic kidney diseases kidney failure
evaluation of the effect of pelvic floor physical therapy on patients with 3rd and 4th degree obstetrical lacerations

Conditions: Obstetrical Lacerations; Obstetric; Injury Pelvic Floor

Summary: the purpose of this study is to determine if patients with third and fourth degree obstetric lacerations benefit from a short course of pelvic floor physical therapy in the immediate postpartum period.

the proposed study is a prospective, randomized pilot trial. we aim to answer the question: do patients with third and fourth degree obstetric lacerations benefit from a short course pelvic floor physical therapy in the immediate postpartum period? forty patients experiencing third or fourth degree obstetric laceration at either bidmc or mount auburn hospital will be identified and randomized in a 1:1 ratio. half of the patients will receive a 10-12 week course of pelvic floor physical therapy at marathon pt to begin one to two weeks postpartum. those assigned to the control will not receive pelvic floor physical therapy which is the current standard of care. they will also agree not to seek pelvic floor physical therapy during until at least 14 weeks postpartum without discussing with study investigators. at 14 weeks postpartum they will be offered pelvic floor physical therapy. at 1-2 weeks postpartum, 6-8 weeks postpartum, and 12-14 weeks postpartum, all study subjects will complete the pelvic floor impact questionnaire - 7 (pfiq-7), the pelvic floor distress inventory - 20 (pfdi-20), the female sexual function index (fsfi), the patient global impression of severity (pgi-s) scale and the patient global impression of improvement (pgi-i) scale all of which are validated surveys. surveys will be completed online via redcap using computers at marathon pt for treatment group subjects and at home or in a location of their choosing for control subjects. control patients will be given the option of beginning pelvic floor pt after 14 weeks postpartum. should they decide to pursue pelvic floor pt at that time, they will have the option to continue to fill out periodic surveys via redcap, but will not be required to do so.

Eligibility criteria:
inclusion criteria: * vaginal delivery at either bidmc or mt. auburn hospital complicated by either third or fourth degree perineal laceration * age 18 or older exclusion criteria: * history of previous vaginal delivery after 24 weeks gestation
prostatectomy prospective database

Conditions: Prostate Cancer

Summary: the purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health.

the purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health. participation in the study will allow collection of medical information related to prostate cancer treatment from hospital and doctor's office records. questionnaires will be completed reflecting bladder, bowel, and sexual function, and quality of life at three, six, twelve, eighteen, and twenty-four months after surgery, and yearly thereafter.

Eligibility criteria:
inclusion criteria: * males greater than 18 years of age * patients having prostatectomy or cryosurgery for the treatment of prostate cancer at william beaumont hospital. exclusion criteria: * dementia

Keywords: prostate cancer prostatectomy
use of mobile technology to prevent progression of pre-hypertension in latin american urban settings

Conditions: Hypertension; Prehypertension

Summary: nearly half of the adult population in latin american urban settings has abnormally high blood pressure. although half of these subjects with high blood pressure are still in the pre-hypertensive stage (systolic blood pressure values in the 120-139 mmhg range or diastolic blood pressure in the 80-89 mmhg range), the rate of progression to hypertension is high (10-20% per year), according to studies done in other settings. the main objective of this proposal is to evaluate the effectiveness of an affordable and sustainable primary health care intervention to reduce blood pressure and prevent progression from pre-hypertensive status to hypertension in individuals at poor urban clinics in argentina, guatemala, and peru. our primary hypotheses are that pre-hypertensive subjects who receive mhealth (mobile health) support for 12 months (intervention group) will have lower blood pressure compared to individuals who receive the usual primary health care (control group); and that pre-hypertensive subjects will maintain lower blood pressure six months after receiving mhealth support. the investigators will determine the effects of an intervention using mhealth technology, including short message services (sms) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants. the intervention also aims to help participants become better informed, motivated, and encouraged to practice self-management of their own health; to improve patient satisfaction levels; provide tailored targeted interventions; and to improve patient-provider relationships. the proposal is designed as a proof-of-concept intervention in three latin american countries that encompass a wide range of environments and health care settings. a total of 212 subjects (30-60 years old) per country will be recruited in primary health clinics and randomized to study groups. blood pressure, anthropometry, and behavioral risk factors (physical activity, diet, stress, alcohol and tobacco use) will be measured at baseline and at months 6 and 12 during the intervention, and six months after the end of the intervention. the investigators will also evaluate feasibility, acceptability, cost-effectiveness, and process implementation of the intervention.


Eligibility criteria:
inclusion criteria: * systolic blood pressure values in the 120-139 mmhg range or diastolic blood pressure in the 80-89 mmhg range * no current anti-hypertensive medication * own a personal cellular phone exclusion criteria: * previous diagnosis/treatment hypertension * illiteracy * another household member already in the study

Keywords: prehypertension blood pressure mobile technology latin america behavioral change healthy lifestyles mhealth